# Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, Division 4.3.3: Toxicology

Extent: E+W+S+N.I.

(a) The toxicity of the finished product shall be assessed. Individual testing of active substance(s), excipients, additional substances and any process-related impurities shall be taken into consideration.
(b) The duration of observations may be longer than in standard toxicity studies and the anticipated lifespan of the medicinal product, together with its pharmacodynamic and pharmacokinetic profile, shall be taken into consideration. A justification of the duration shall be provided.
(c) Conventional carcinogenicity and genotoxicity studies shall not be required, except with regard to the tumourigenic potential of the product.
(d) Potential immunogenic and immunotoxic effects shall be studied.
(e) In the case of cell-based products containing animal cells, the associated specific safety concerns such as transmission to humans of xenogeneic pathogens shall be addressed.

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Source: https://www.legislation.gov.uk/eudr/2001/83/annex/I/part/IV/division/4/division/4.3/division/4.3.3 (the official version)
Page: https://openlegislation.uk/eu-directive-2001-83/annex-I/part-IV/division-4/division-4.3/division-4.3.3
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.